Aradigm has announced that the FDA has designated its Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis patients as a Qualified Infectious Disease Product (QIDP). QIDP status makes the product eligible for the FDA’s Fast Track expedited review program.
Aradigm CEO Igor Gonda said, “We are very pleased that the FDA has granted QIDP designation to Pulmaquin. Persistent lung infections with Pseudomonas aeruginosa are a key factor related to the poor quality of life and untimely death in non-cystic fibrosis bronchiectasis patients. The QIDP designation will accelerate the advancement of Pulmaquin development as a potential treatment for these patients.”
Grifols acquired worldwide rights to Pulmaquin and Aradigm’s other inhaled ciprofloxacin formulation, Lipoquin, in May 2013. As part of that deal, Grifols agreed to pay for Phase 3 development and, according to Aradigm, two pivotal trials of Pulmaquin for the non-CF bronchiectasis indication are planned.
Read the Aradigm press release.
